LENIAS HWENDA: African regulators must take a stand against substandard medicines

According to the World Health Organisation (WHO), almost 2- billion people worldwide, and roughly half of Africa’s 1.3-billion people, do not have regular access to basic medications. This leads to the deaths of millions of Africans each year. Women and children, especially the poorest, bear the brunt of this.

The problem of poor access to medicines persists in large part because Africa does not have the industrial base to make sufficient medicines to meet its population’s health needs. According to a 2019 McKinsey report, the continent has only about 375 pharmaceutical manufacturers, and most of these are concentrated in North Africa, which despite being part of the continent has little cultural or trade connection with Sub-Saharan Africa.

Outside North Africa, most manufacturing operations on the continent are concentrated in just nine out of 46 countries. To put into perspective just how small a number this is, India and China have comparable size populations to Africa, and China has 5,000 manufacturers and India 10,500. Africa’s 375 manufacturers barely scratch the surface in meeting local medical needs that grow in magnitude each year, accelerated by climate-driven disease outbreaks.

The result is that more than 90% of medicines needed by Africans, and 99% of its vaccines, are imported, mainly from India. Indian manufacturers are estimated to produce 90% of the antiretrovirals (ARVs) that donor government funds procure for people in African countries and other low- and middle-income countries, for instance. 

Africa’s excessive dependence on imports has made it extremely vulnerable to medicine shortages. This is a major driver of the high prevalence of counterfeit medical products in African markets. Africa accounts for the biggest share of counterfeit medical products in the world at 42%. Half a million Africans lose their lives each year due to substandard medications.

India is a major source of the substandard or falsified medical products that are flooding the African market. It is not alone in this, but its position as the biggest single supplier to a continent that is poorly regulated worsens the situation. Media reports, including in Indian media, have painted a troubling picture of generally poor regulation of medicines manufactured in India. The Indian regulatory authority, Central Drugs Standard Control Organisation, has been accused of looking the other away when Indian manufacturers produce medicines for export to Africa in particular. 

No-one knows the exact volume of substandard medicines deliberately exported to African markets. What we do know is that according to the WHO about half-a-million Africans die each year from taking substandard medicines, and that this figure is most likely an underestimate. The global counterfeit medicines market is estimated to be worth $200bn.

The prevalence of counterfeit medicines in the African context will have been worsened by the fact that efforts to improve access to medicines in African nations have focused primarily on improving the availability of medicines, relegating quality to a secondary concern. This is particularly consequential given that most of those medicines are bought from poorly regulated medicine manufacturing environments such as India.

Demand for made-in-India medicines is high partly because of the price, and the poor nations to which the medicines are exported have limited capacity to perform regulatory checks to prevent abuses. These factors combine to have devastating consequences for African patients.

The recent example of children in Gambia who were allegedly killed by contaminated cough syrups made by an Indian company — Maiden Pharmaceuticals — is a case in point. The case, which is before the courts, demonstrates the potential public health threat posed by the quality of medicines made in India for the African market.

Despite extensive coverage of the case, cough syrups manufactured in India are still on the shelves in Gambia, and continue to make their way onto the wider African market with little to no regulation. This tells us that this problem is not going away soon. If anything, given the scale of the global counterfeit medicines market, we can expect it to grow.

It is clear that Indian regulators are unable or unwilling to act. The world has feted India as the pharmacy of the world, serving the medical needs of the world’s most vulnerable with treatments they would otherwise not be able to afford. But the world has neglected to insist that the medicines India makes for the African market in particular are regulated and as safe as those sold to its own people.  

The sheer volume of substandard medicine imports sold in Africa raises serious questions about the overall impact on population health and treatment outcomes. It is worth noting that despite progress in improving access to antiretroviral treatments for HIV, Africans still account for the biggest share of new HIV infections globally.

According to the Global Fund, more than half of new HIV infections globally in 2022 were in Africa. Yet we know that when people with HIV are treated effectively with antiretrovirals their viral loads are reduced significantly, limiting their ability to transmit HIV to others. With more than 70% of Africans with HIV on the continent receiving treatment, why is the transmission rate among Africans remaining so stubbornly high? Could it be because the millions on medication are not being treated effectively because the medications are substandard?

Of course, there are other factors that influence treatment outcomes, but given that Indian manufacturers produce about 90% of the antiretrovirals taken by Africans, and the known poor track record of the Indian medicines regulatory authority, it is fair to ask whether substandard medicines may be partly responsible for HIV remaining so prevalent in Africa.

In an ideal world, regulators overseeing manufacturing facilities, such as the CDSCO, would check that medicines being manufactured for export are safe and work as expected. Alongside that, regulators in markets to which medicines are exported would perform similar checks to ensure the medicines that land on their shores are what they are supposed to be. Yet for many African patients both of these mechanism are failing. In Gambia, it seems that both Indian and Gambian regulators failed, with the result that African lives were lost. 

SA Health Products Regulatory Authority CEO Dr Boitumelo Semete-Makokotlela has labelled imports of substandard medicines an existential threat that is having a seriously negative effect on the wellbeing of Africans. The African Medicines Agency (AMA), which is on the verge of being launched by the AU, is expected to help mitigate this threat, but it is a case of David versus Goliath. The Indian pharma industry is the third largest globally by volume and was worth $65bn in 2024. It is projected to reach $130bn by 2030.

Nevertheless, in the wake of the Gambia tragedy both the AU and African country regulators must take a stand. The act of taking medication as an African should not amount to playing Russian roulette. There should be one universal standard for the quality of medicines taken by all people anywhere in the world. Allowing cheap but poor quality medicines to be sold to Africa is unethical. The people of the continent deserve better. 

• Dr Hwenda is founder and CEO of Medicines for Africa.